**Who we want**- ** Business-oriented evaluators.
** People who effectively interpret information to demonstrate the effects of business initiatives and industry trends for sales, management and leadership teams.- ** Self-directed initiators.
** People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.- ** Analytical problem solvers.
** People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.
**What you will do**- Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.- Ensure quality of process and product as defined in the appropriate operation and material specifications.- Will select components and equipment based on analysis of specifications, reliability and regulatory requirements.
Work with quality engineers to develop component specific testing and inspection protocols.- May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.- Will analyze equipment to establish operating data, conduct experimental test and result analysis.
Lead and/or participate in process review meetings.- Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.- Complete capability studies for in process inspection and generate subsequent Inspection documentation.- Conduct MSA studies for new products and new processes.- Provide training for manufacturing team members.- Ensure adherence to GMP and safety procedures.- Review and approval of validation documentation.
**What you will need**- B.S in Industrial Engineering or related engineering discipline; - +3 years of similar experience in a Highly Regulated Industry; - Experience in executing complex problem-solving techniques related to manufacturing/design technical issues; - Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques; - Excellent analytical skills, ability to plan, organize and implement concurrent tasks; - Good knowledge of manufacturing processes, materials, product and process design; - Excellent attention todetail; - Bilingual in English and Spanish.